This is an open-label and phase IV study of full face injections of variable doses of BT-A. As it is an open-label and not blind study, both investigator and subjects will know the injection local and doses of the study drug. Patients will be randomized into 3 different groups. Each group will receive a specific dose according with the indication evaluated by the investigator. Six visits will be schedule in this study.

The following list shows the indications for eligibility and total doses that will be applied in each part of the face, according to the consensus meeting recommendations, at the 1 visit:

Upper face:

Crow's feet wrinkles - 70 U

Glabella - 50 U

Forehead - 40 U

Mid face:

Lower eyelid - 5 U

Nasal wrinkles - 20 U

Malar wrinkles - 10 U

Lower face:

Peri-oral wrinkles - 15U

Asymmetric smile or gummy smile - 5U

"Cellulitic chin" - 20U

Marionette lines - 25 U According to the patients needs, the doses can vary ±10% in terms of the amount of units that will be injected.

Patients will be allocated in each group according to the total dose received at visit 1(described above). At visit 2, all the patients will receive a touch-up of a standard dose of 25 Units of Dysport®, distributed on the treated areas according patient's needs.

Active Comparator: 171 to 210 U of BT-A

Drug: Botulinum toxin

The following list shows the indications for eligibility and total doses that will be applied in each part of the face, according to the consensus meeting recommendations, at the 1 visit:

Upper face:

Crow's feet wrinkles - 70 U

Glabella - 50 U

Forehead - 40 U

Mid face:

Lower eyelid - 5 U

Nasal wrinkles - 20 U

Malar wrinkles - 10 U

Lower face:

Peri-oral wrinkles - 15U

Asymmetric smile or gummy smile - 5U

"Cellulitic chin" - 20U

Marionette lines - 25 U According to the patients needs, the doses can vary ±10% in terms of the amount of units that will be injected.

Patients will be allocated in each group according to the total dose received at visit 1(described above). At visit 2, all the patients will receive a touch-up of a standard dose of 25 Units of Dysport®, distributed on the treated areas according patient's needs.

Active Comparator: 211 to 250 U of BT-A

Drug: Botulinum toxin

The following list shows the indications for eligibility and total doses that will be applied in each part of the face, according to the consensus meeting recommendations, at the 1 visit:

Upper face:

Crow's feet wrinkles - 70 U

Glabella - 50 U

Forehead - 40 U

Mid face:

Lower eyelid - 5 U

Nasal wrinkles - 20 U

Malar wrinkles - 10 U

Lower face:

Peri-oral wrinkles - 15U

Asymmetric smile or gummy smile - 5U

"Cellulitic chin" - 20U

Marionette lines - 25 U According to the patients needs, the doses can vary ±10% in terms of the amount of units that will be injected.

Patients will be allocated in each group according to the total dose received at visit 1(described above). At visit 2, all the patients will receive a touch-up of a standard dose of 25 Units of Dysport®, distributed on the treated areas according patient's needs.

Subjects that never received BT-A or who had previous injections of BT-A in no more than one third of the face with in the last 6 months;

Subjects presenting at least two indications for treatment with BT-A in each third of the face;

Medical history and physical examination which, based on the investigator's opinion, do not prevent the patient from taking part in the study and use the product under investigation;

Subjects of childbearing age should present a negative urine pregnancy test (instant test) at baseline and should be using an effective contraceptive method (oral or injectable contraceptive, for at last three months, and use of preservative; subjects with: hysterectomy, oophorectomy or tubal ligation);

Availability of the patient throughout the duration of the study (24 weeks);

Subjects that agree not to undergo other cosmetic or dermatological procedures during the study;

Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by the study protocol.

Exclusion Criteria:

Pregnant women or women intending to become pregnant during the study;

Subjects participating in other clinical trials;

Presence of scars on the face that may interfere with the result of study;

Subjects with neoplastic, muscular or neurological diseases;

Concurrent use of treatments that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle and aminoglycoside antibiotics.

Subjects with inflammation or active infection in the face;

Subjects with a history of sensitivity to the components of the formula;

Subjects clinically diagnosed anxiety disorder or any significant psychiatric disorder (e.g. depression) that, in the opinion of the Evaluator, might interfere with the Subject's participation in the study;

Subjects with a history of medical treatment non-adherence or showing unwillingness to adhere to the study protocol.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032954